Validation Analyst

The world isn’t standing still, and neither is ATS Life Sciences - We don’t follow the trends. We set them! 

Are you interested in being part of a team that makes a difference? Join our growing ATS Life Sciences Systems team a division of ATS Corporation, a publicly traded global enterprise with a proud history, we are helping advance the future with our factory-wide automation solutions. Within Life Sciences Systems, what we do matters – we custom design, build and service critical automated solutions for medical device and pharmaceutical companies. We are dedicated to assisting our customers in improving the quality of life for people around the world. When there is no room for error, and product failure is not an option, leading life sciences companies trust us to resolve their production challenges. 

Job Description

MAJOR DUTIES:

Provide the coordination, creation and execution of validation activities including (but not limited to) writing protocols, performing qualifications, review of documents that support the manufacturing of automated equipment on single module custom machines, medium sized multi-module systems or replication projects. In addition, the candidate will understand how the various pieces of automated equipment operate and understand the principle of Life Science Validation and Engineering.

SPECIFIC RESPONSIBILITIES:

· Administer, create, maintain and execute validation plans, procedures and protocols for projects, with the assistance of technical and engineering personnel and team members

· Work with project team members to design and develop custom test plans for projects based on similar projects and templates and engineering knowledge

· Work with technical and engineering personnel to prepare and create validation related documentation and functional specification documentation for projects.

· Develop equipment validation master plans with the assistance of team members

· Lead review meetings with the internal team and customers to review and approve validation related documentation

· Assist in the coordination and delivery of all validation documentation provided to customers, including printed and electronic copies.

· Perform machine testing and qualification on shop floor at ATS and occasionally at customer sites.

· Use technical skills to perform testing such as interfacing with the PLC to conduct I/O testing

· Coordinate and participate in the generation and completion of any deviations, equipment and document change control resulting from a qualification and /or validation activity.

· Regularly monitor project status, record validation documentation status and report status to validation and project teams.

· Ensure that project records are kept and archived in accordance with ATS procedures.

· Assist with the development and updates of customer and internal validation, machine acceptance test protocols and supporting documents.

· Interface with manufacturing, Mechanical and Controls Engineering group

· Adhere to all aspects of the department procedures.

· Perform other duties as assigned.

· Occasional overtime and weekend work may be required.

· Ensure that all business activities are performed with the highest ethical standards and in compliance with the ATS Code of Business Conduct.

· Adhere to all health and safety rules and procedures.

· Contribute to the development and maintenance of internal standards.

QUALIFICATIONS:

· Bachelor’s degree in science (engineering, physics or chemistry preferred) or equivalent experience and greater than 2 years of directly related experience.

· Technical understanding of pharmaceutical / biotechnology unit operations.

· Technical understanding of general automation equipment design and principles.

· Strong communication, technical problem solving, and interpersonal skills.

· Good knowledge of cGMP requirements and current Life Science industry practices is preferred.

· Demonstrate ability to work in a cross-functional team environment.

· The ideal candidate will possess excellent planning and coordination skills and be able to readily adapt to changes in priorities and project schedules.

· Prior experience with automation equipment, Life Science equipment validation and project engineering would be an asset.

· Knowledge of computer programs such as Windows, Excel, Word, Outlook and Project. Should have working knowledge of AutoCAD and Solid works as well as some understanding of PLC programming software like RSLogix or Siemens Step 7

· Ability to travel in the USA and Europe

Additional Information

ALL EMPLOYEES HAVE THE RESPONSIBILITY TO WORK IN A SAFE MANNER AND REPORT ANY HEALTH, SAFETY OR ENVIRONMENTAL CONCERN TO THEIR MANAGER OR SUPERVISOR IN A TIMELY MANNER.

EMPLOYEE RESPONSIBILITIES FOR HEALTH, SAFETY AND ENVIRONMENT INCLUDE:

· Work in compliance with divisional health, safety and environmental procedures

· Refrain from removing or altering safety devices or guarding unless hazardous energies are controlled through lockout-tagout methods

· Report any unsafe conditions or unsafe acts

· Report defect in any equipment or protective device

· Ensure that the required protective equipment is used for the assigned tasks

· Attend all required health, safety and environmental training

· Report any accidents/incidents to supervisor

· Assist in investigating accidents/incidents

· Refrain from engaging in any prank, contest, feat of strength, unnecessary running or rough and boisterous conduct

If you're excited about this role, but do not meet all the qualifications listed above, you are still encouraged to apply

Why YOU should join our ATS Life Sciences Systems team:  We value our PEOPLE - The foundation of a great company is having the best team which is why we continuously work to develop, engage, empower and energize our people. The best people want to work with the best team - the best teams are diverse and inclusive teams.

What we do MATTERS - our Life Sciences projects contribute to improving the lives of people around the world! ATS has made a commitment to be carbon neutral by 2030!  INNOVATION and PROBLEM SOLVING is at our core - Our pursuit of continuous improvement in everything we do. Our focus is on building diverse teams, stimulating innovation by challenging conventional thinking, encouraging fresh ideas and promoting creative problem-solving We prioritize internal GROWTH & DEVELOPMENT - ATS offers endless opportunities for professional growth and development – with a tuition reimbursement program, individual development programs and a commitment to promoting from within - there is space for you to grow your career at ATS! 

 
We offer COMPETITIVE Total Rewards - Competitive starting salaries, overtime pay eligibility, paid vacation, Employee Incentive Bonus program, comprehensive health and dental benefits including Lifestyle Spending Account, 4% RRSP matching program and optional Employee Share Purchase Program 

 
A place to BELONG: We celebrate our differences and ensure that all employees have equal opportunities for growth and development. We believe that diversity of thought, background, and experiences is essential for our success and innovation.

ATS is in compliance with the Accessibility for Ontarians with Disability Act (AODA), 2005 and will, upon request, assist those who may require specific accommodations due to a personal disability. We would ask that those who require assistance to notify our offices as soon as possible if accommodation is necessary